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GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

A ruling in Oklahoma that Johnson & Johnson’s marketing efforts created a public nuisance may establish a precedent of other jurisdictions.

The transaction is part of Bristol-Myers Squibb’s proposed acquisition of Celgene.

The divestiture is in line with Bayer’s strategy to focus on its life sciences business.

Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.

Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.

The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.

The acquisition will boost Merck’s pipeline for cancer, fibrosis, and autoimmune disease therapeutics.

The current president of Novartis’ Advanced Accelerator Applications has been appointed as the new Novartis Pharmaceuticals president.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

Paul Hudson, formerly CEO of Novartis Pharmaceuticals, has been tapped to succeed Olivier Brandicourt as CEO of Sanofi.

The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.

The agency has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy to treat pediatric spinal muscular atrophy.

The acquisition will expand Pfizer’s rare disease portfolio with an early pipeline candidate for treating dwarfism.

Novartis will acquire assets associated with Takeda Pharmaceuticals’ Xiidra (lifitegrast ophthalmic solution) 5%, an eye-care drug.

Sandoz’s new CEO will assume responsibilities no later than Aug. 1, 2019.

Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.

Shareholders have approved the issuance of Bristol-Myers Squibb common stock for the pending $74-billion merger with Celgene.

With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.

Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.

A $1.7-billion acquisition CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.

Richard Francis will step down as CEO of Sandoz, effective March 31, 2019.

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.